SUSONITY
Process Validation Expert(m/w/x)
Full-timeOn-siteSenior
Aubonne
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Managing IT/OT projects for pharma and medical device development, including supplier qualification and FAT/SAT verification. Engineering degree with 5+ years in pharma and 3+ years in automation required. Focus on GMP standards and OT systems for internal supplier interface.
Requirements
- Engineering degree in IT/industrial IT
- At least 5 years experience in pharma/medical devices/biotech
- At least 3 years experience in automation and IT systems
- Good knowledge of OT systems for internal supplier interface
- Good knowledge of GMP standards
- Taste for challenges and large-scale projects, results-oriented
- ITIL knowledge is a plus
Tasks
- Analyze needs and define specifications
- Write and manage tender documents
- Select and qualify suppliers
- Verify IT/OT documentation
- Monitor commissioning, FAT/SAT, and deployment
- Supervise validation and qualification plan execution
- Lead improvements on existing equipment according to GMP standards
- Coordinate activities for deployment and qualification
Work Experience
- 4 - 9 years
Education
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SUSONITY and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Managing IT/OT projects for pharma and medical device development, including supplier qualification and FAT/SAT verification. Engineering degree with 5+ years in pharma and 3+ years in automation required. Focus on GMP standards and OT systems for internal supplier interface.
Requirements
- Engineering degree in IT/industrial IT
- At least 5 years experience in pharma/medical devices/biotech
- At least 3 years experience in automation and IT systems
- Good knowledge of OT systems for internal supplier interface
- Good knowledge of GMP standards
- Taste for challenges and large-scale projects, results-oriented
- ITIL knowledge is a plus
Tasks
- Analyze needs and define specifications
- Write and manage tender documents
- Select and qualify suppliers
- Verify IT/OT documentation
- Monitor commissioning, FAT/SAT, and deployment
- Supervise validation and qualification plan execution
- Lead improvements on existing equipment according to GMP standards
- Coordinate activities for deployment and qualification
Work Experience
- 4 - 9 years
Education
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SUSONITY and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
SUSONITY
Industry
Healthcare
Description
Das Unternehmen entwickelt Medikamente, intelligente Geräte und innovative Technologien in Therapiegebieten wie der Onkologie, Neurologie und Fruchtbarkeit.
Not a perfect match?
- SUSONITY
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Senior Manager Medical Device Program Lead(m/w/x)
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Full-timeOn-siteManagementEysins - SMO Medtronic Europe Sàrl
Equipment Development Engineer(m/w/x)
Full-timeOn-siteExperiencedLausannefrom CHF 92,000 - 138,000 / year - SMO Medtronic Europe Sàrl
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Full-timeOn-siteExperiencedTolochenazfrom CHF 92,000 - 138,000 / year